A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma.
18 Years
N/A
Both
Multiple Myeloma, Diffuse Large B-Cell Lymphoma, Glioblastoma Multiforme, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Neuroendocrine Tumors of Non-Pancreatic Origin, Hormone Receptor-Positive Breast Cancer
Trial Information
A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma.
Initially, patients will be treated with oral CC-223 for one month. During this time,
various tests (involving blood and urine collections, ECGs, etc) will be performed. Those
whose tumors stabilize or regress may continue receiving treatment for as long as they
benefit from CC-223. Different dose levels of CC-223 will be tested in a dose-rising study
design.
Inclusion Criteria:
- Histologically-confirmed advanced solid tumor, Non-Hodgkin Lymphoma or multiple
myeloma
- Patients have not tolerated or progressed on standard therapy, and no further
standard therapy is available
- Archival and screening tumor biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (solid tumors), 0-2
(hematologic malignancy)
- Adequate organ function
Exclusion Criteria:
- Prior systemic cancer-directed treatments or investigational drugs within 4 weeks or
5 half lives, whichever is shorter, prior to starting study drug or who have not
recovered from side effects of such therapy. Subjects must have recovered from any
effects of recent radiotherapy that might confound the safety evaluation of study
drug
- Symptomatic brain metastases (prior Rx and stable metastases are OK)
- Acute or chronic liver or renal disease or pancreatitis
- Diarrhea ≥ Grade 2, impaired GI absorption
- Impaired cardiac function
- Diabetes requiring Rx, glucose >126 mg/dL, HbA1c ≥6.5%
- Peripheral neuropathy ≥ Grade 2
- Pulmonary fibrosis
- Known HIV infection
- Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity in
subjects with HCC
- Pregnant, inadequate contraception
- Most concurrent second malignancies
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety
Outcome Description:
To determine the safety profile and dose-limiting toxicity of CC-223 using NCI CTCAE v4.
Outcome Time Frame:
From the time of informed consent, throughout dosing period and for 21 days after the last dose of CC-223
Safety Issue:
Yes
Principal Investigator
Kristen Hege, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Celgene Corporation
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CC-223-ST-001
NCT ID:
NCT01177397
Start Date:
July 2010
Completion Date:
February 2016
Related Keywords:
- Multiple Myeloma
- Diffuse Large B-Cell Lymphoma
- Glioblastoma Multiforme
- Hepatocellular Carcinoma
- Non-Small Cell Lung Cancer
- Neuroendocrine Tumors of Non-Pancreatic Origin
- Hormone Receptor-Positive Breast Cancer
- Advanced solid malignant neoplasms,Non-Hodgkin Lymphoma,
- Multiple Myeloma
- Breast Neoplasms
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Glioblastoma
- Lung Neoplasms
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Neuroendocrine Tumors
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| NYU Cancer Institute | New York, New York 10016 |
| University of California at San Francisco | San Francisco, California 94115 |
| Billings Clinic | Billings, Montana 59107-7000 |
| Moffitt Cancer Center & Research Institute | Tampa, Florida 33612-9497 |
| Mary Crowley Cancer Research Centers | Dallas, Texas 75201 |
| Sarah Cannon Research Institute (SCRI) | Nashville, Tennessee 37203 |
| UCLA Neuro-Oncology Program | Los Angeles, California 90095-1769 |
| Cedars-Sinai Medical Center-Samuel Oschin Comprehensive Cancer Institute | Los Angeles, California 90048 |
| John Theurer Cancer Center at Hackensack University | Hackensack, New Jersey 07601 |
